NL-OMON44991已完成3 期
A multi-center randomized, open label, controlled study in primary liver transplantation comparing long term renal function in recipients treated with standard dose extended release tacrolimus alone and recipients treated with a combination of low dose extended-release tacrolimus and low dose sirolimus. - LOL III
Stichting Leveronderzoek0 个研究点目标入组 196 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 196
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Primary liver transplantation or retransplantation within 14 days after first transplantation
- •* Use of Advagraf at least 2 weeks prior to randomization
- •* Patent hepatic artery
- •* Closed abdominal wound
- •* Stable graft function
- •* Positive informed consent at time of randomization
- •* Age 18-70 years
排除标准
- •*Treatment with investigational drugs within 3 months before start of therapy
- •*Multi organ transplantation
- •*cGFR < 30 ml/min
- •*Proteinuria > 800 mg/24 h
- •*Hypersensitivity to sirolimus
- •*Thrombocytes < 50 x 109 /L
- •*Leukocytes < 2.5 x 109 /L
- •*Haemoglobin < 6 mmol/L
- •*Biopsy proven rejection 2 weeks prior to randomization
- •*HIV positivity
- •*Signs of recurrent or de novo cancer
- •*Pregnancy or breast feeding
- •*Systemic infection
- •*Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the study
研究者
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